BIVDA responded to the MHRA’s focused consultation on the proposed Pre-Market amendment to the UK Medical Device Regulation. The consultation, which closed on 5th January, focused on:
- International Reliance and associated pathways
- Proposal to remove the requirement for a physical UKCA mark
- Proposed route for UK Conformity Assessment
- Renewal of four pieces of assimilated EU law into UK Law which face sunsetting in 2025 before replacement UK legislation is drafted
Based on the feedback received, members were generally supportive of the proposals. In our response, we suggested a numbcr of areas where the MHRA may want to develop their high-level suggestions and also highlighted the need for detail behind the draft legislation.
We await the draft legal text for these aspects and the wider Pre-Market amendments to the UK MDR 2002. We look forward to continue to work with the MHRA as a trusted advisor on the proposal and future guidance.
The Pre-Market Statutory Instrument is due to be published late 2025.
